Narayan Kulkarni
To
a large extent Food Safety and Standards Authority of India (FSSAI) has created
a level playing field among stakeholders of the industry, which is waiting to
see the authority to build strength, regulate the market and streamline and
accelerate the process of product approvals to that the local nutraceuticals
industry can become a leading player in the global market.
The Indian Parliament passed Food Safety and Standard Act in 2006 (FSSA), to
integrate and streamline the many regulations covering nutraceuticals,
functional foods and dietary supplements, as the industry has been facing
issues such as multiple food laws, varied standards that are restricting
innovation, limited manpower, poor labs and infrastructure, rigid standards,
non-responsive to scientific advancements and modernisation and poor level of
consumer interface. Food Safety and Standard Act of 2006 will ensure improved
quality of food for the consumers and censure misleading claims and
advertisement by those in food business.
The
Food Safety and Standards Act 2006, which came into effect from August 5, 2011,
five years after it was passed in
Parliament, subsumes eight different Central Acts. It will ensure prevention of
fraudulent, deceptive or unfair trade practices, which may mislead or harm the
consumer, and unsafe, contaminated or sub-standard food.
An authority – The Food Safety and Standards Authority of India (FSSAI) – was
established in 2008 under the overarching legislation to implement the Act,
which will lay down science-based standards for food items and regulate their
manufacture, storage, distribution, sale and import to ensure availability of
safe and wholesome food for human consumption.
Immediately
after announcing the opening of FSSAI, the first Chief Executive Officer, V N
Gaur, said, “the Food Safety and Standards Authority will broadly frame
regulations to lay down the standards and guidelines for food items and specify
an appropriate system of enforcing various standards. It will specify
mechanisms for accreditation of certified bodies engaged in certification of
food safety management system for food businesses, and procedures for
accreditation of laboratories.”
As
rightly pointed out by Sanjay Dave, Chairperson, Codex Alimentarius Commission,
The Food Safety and Standards Authority of India was established as a single
reference point for all stake holders of the industry to help achieve high
degree of consumer
confidence; to work as an effective and transparent regulatory framework; to
provide adequate information to consumers for informed choice; to help in
decentralisation of licensing; to provide integrated response to novel/
genetically modified foods, trade, etc. and also to help in speedy disposal of
cases.
In
the last two years of existence, the FSSAI has constituted apex scientific
committees to provide scientific opinion to the authority on wide range of
subjects that are within the mandate of the authority. The Scientific Panels on
Functional Foods, Food Additives, Method of Sampling and Analysis, Biological
Hazards, Contaminants in Food, Pesticides and Antibiotic Residues, Genetically
Modified Organisms and Food and Labelling, claims/advertisements have been
formed. It has also begun the exercise of harmonising the standards for the
various food items.
As required under the Act, 22 States
and Union Territories have Food Commissioners in place, while seven are to
follow. All the states have operationalised the FSS (Licensing and Registration
of Food businesses) Regulations, 2011. About 2,77,801 licences and 8,60,119
registrations have been issued by the state governments as of March 2013. At
the Central level, 9,348 licences have been issued till March 11, 2013.
Making a new beginning
The FSSAI has taken many initiatives for fixing standards of food articles.
These initiatives from the government received mixed responses from different
stakeholders of the industry.
Hailing the new initiatives, V S
Reddy, Chairman and Managing Director, British Biologicals, said, “Indian
consumers have never been known to question a product’s efficacy in the past.
Given this scenario, it is really heartening to note that at last there is a
regulatory system in place at the Government of India level to protect their
interest. The consumer will now be ensured of quality and science based
products and dubious products will be weeded out. Substandard products will
leave the market and it will leave a positive impact on the industry.”
“The new system is a blessing for all stake holders. And it definitely helps
the industry,” said Reddy and added, “First and foremost, it brings
accountability into the system, both at industry level as well as at the
consumer level. Secondly, it helps in bringing quality products at competitive
prices to the end consumer. The regulatory body will also be a huge support in
terms of spreading awareness on the benefits of disease specific nutritional
products. By and large, it helps in the growth of the industry and the need of
the hour has been met with this controlling authority.”
Chairman and Managing Director of Avesthagen, Dr Villoo Morawala-Patell, said,
“We have a good policy. The new Act will help the industry but it needs to be
implemented and followed. We will deliver good and well priced quality products
to the public.”
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Different Acts brought
under FSSA 2006
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- Vegetable Oil Products
(Control)
- Order of 1947
- Prevention of Food
Adulteration Act of 1954
- Fruit Products Order of 1955
- Any order issued under the
Essential Commodities Act, 1955
- Essential Commodities Act,
1955 relating to food
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- Solvent Extracted Oil, De-
Oiled Meal and Edible Flour (Control) Order of 1967
- Meat Food Products Order of
1973
- Edible Oils Packaging
(Regulation) Order of 1988
- Milk and Milk Products Order
of 1992
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Initiatives of FSSAI
for fixing of standards of food articles
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1. Draft standards for caffeinated
beverages have been formulated and are under notification for seeking public
comments.
2. Draft notification for fixation of limit of trans fatty acid in partially
hydrogenated vegetable oil, has been notified for seeking public
comments.
3. Draft notification for fixing standards for antibiotics in Honey, has been
notified for seeking public comments.
4. Draft standards for olive oil have been notified for seeking public
comments.
5. Regulations of alcoholic drink – alcoholic drink has been defined as food
under Food Safety and Standards Act 2006 and the process of framing standards
and regulation thereof has begun. After following the prescribed process of
standards setting, the same would be brought to the food authority for
discussion.
6. Draft regulations of imported food safety have been framed.
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Sharing his views, Dr Dilip Ghosh, Director at Nutriconnect, Sydney, Australia,
says, “It was a very bold and much-needed framework for both Indian industries
as well as global companies, who are in the process of entering Indian market.
But due to legacy of bureaucratic system, it is still uncertain about the final
outcome of this regulatory framework. I am looking with great interest how SMEs
are responding to these changes. Still effective patent protection of
innovative clinically proven natural medicines/ nutraceuticals is a big problem
in India.”
The most important trend in the food safety standards is that it takes a
holistic view of the problem and comes out with solutions, which are acceptable
to the industry. “The FSSAI standards are very helpful to the industry as it
gives insight to the fine points, which normally are overlooked by the industry
and create problems. The regulatory system needs more effective implementation
by government, who must train their staff on regular basis as there is a
dynamic process of novel products coming into the market and consumers are not
fully aware of the benefits. The government has to intervene to protect the
consumer from fly-by-night operators,” said Kumar Bhatia, Adviser, Ministry of
Food Processing Industries and former Managing Director, National Seeds
Corporation.
“Implementation of FSSAI Act is welcome for our growth and top up with our
quality and access in international clients and markets. This new regulation
perhaps may be the ideal one where it provides a wide spectrum of regulatory
clarity making approval process stronger. Thus providing confidence among
global consumers where there is a clear distinction on use of ingredients
–between drug and food use – unlike other softer approval process in some of
the leading countries,” points out Dr Baidyanath Mishra, Vice-President,
Product Development, Regulatory and Medical Affairs, Katra Phytochem.
Need to address more concerns
By defining the nutraceuticals, functional foods and novel foods categories
FSSA has given the much needed structure required to develop this emerging
segment. Reacting to the changes in regulatory set up, Frost & Sullivan
said, "The food industry sees the FSSA as a mixed blessing. This would
enable the companies in this segment to clearly differentiate themselves from
'poser' products. As a result, not only the companies benefit but the consumer
is also able to make an informed choice. However, the authority is yet to
clarify on overlaps among the definitions leading to potential confusion. Until
this area is clearer, the companies may find it difficult to adapt the new
practices ultimately increasing the time to market new products."
While, features such as single window for licences and special courts to settle
disputes have been welcomed, Frost & Sullivan further said, "The
industry is still worried about the FSSA due to various concerns. For example,
the food safety administration is understaffed and 250 (approximate) food
sample testing labs that currently exist in India are insufficient. Only
increase in number of testing labs and staff will help to enforce the upcoming
regulation. While the government is planning to launch another 125
(approximate) food testing centres over the next few years, this represents an
opportunity for private players to enter this space. Also, while companies
expect the lead time to settle litigations and implement their expansion plans
to decrease drastically when the FSSA policies are implemented, the related
costs are unclear. Furthermore, the cost of implementation of new regulations
is most likely to be passed onto the consumer, resulting in increased food
prices."
Making his point, Prof Huub L M Lelieveld, President, Global Harmonization
Initiative (GHI), GHI Association, The Netherlands, said, "India is a very
large country and correct regulations alone will not achieve the goals of the
law. In most countries inspection is insufficient to prevent malpractices.
Therefore, there must be ample attention to inspection, meaning that
knowledgeable inspectors are needed and these must be educated and trained.
This needs to be stimulated so that there will not just be enough inspectors in
the future, but also that they will have the required capabilities. This
applies equally to all food products, including neutraceuticals."
Says Dr Ghosh of Nutriconnect,
"I see a bright future for the Indian industry, which is involved with
food, nutritional, nutraceutical and natural medicine’s research and
development, commercialisation and marketing areas. There are few grey areas
such as food-medicine interface need to be analysed and regulated properly. The
regulatory scheme of non-prescription drugs is not very clear."
The concept of
"nutraceuticals" is still developing in India and there are no
regulations dealing specifically with nutraceuticals or functional foods. K V
Venugopalan, President, Indian Analytical Industry Association, said, "It
is also essential to have specific regulations as regards to product approval,
approval of claims, permitted additives, quantity of vitamins and minerals etc.
for nutraceuticals as it is necessary to treat this segment as independent and
unique entity under the Food Safety Standard Act 2006. Once these regulations
are in place and implemented properly, it will benefit the consumers to a great
extend as well as the Instrument suppliers as the market opens up for large
scale investments."
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Achievements So Far
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- Food Commissioners in place
22 States and Union Territories
- FSS (Licensing and
Registration of Food businesses) Regulations, 2011 operationalised in
all states
- Over 2.77 lakh licences and
8.6 lakh registrations issued by the state governments till March 2013
- Over 9,000 licences issued at
the Central level, till March 11, 2013
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Areas of Concern
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- No clarity yet on overlaps
among the definitions leading to potential confusion with companies may
finding it difficult to adapt the new practices leading to delay in
marketing new products
- Understaffed administration;
Insufficient food sample testing labs
- Need for ample attention to
inspection, requiring knowledgeable inspectors, who are educated and
trained
- Food-medicine interface need
to be analysed and regulated properly
- Lack of clarity about when a
product is main line food and when supplement
- Inadequate fund allocation
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Reacting sharply to the developments about the new regulations on
nutraceuticals industry, Dr R K Sanghavi, Chairman - Nutraceutical
Subcommittee, Indian Drug Manufacturers’ Association (IDMA), said,
“Nutraceutical industry will be suffocated to death and Food Business Operators
(FBOs) will churn out useless products (homeopathic quantities) for business
continuation resulting in depriving patients of real benefits of alternative
natural products.”
Airing similar sentiments, Krishna
Kumar Joshi, head, Regulatory Affairs, Foods Division, ITC Ltd, said, "The
draft regulation made is not comprehensive and lacks many aspects such as lack
of clarity when a product is main line food and when supplement; lack of
comprehensive regulation like Dietary Supplement Health And Education Act of
1994 (DSHEA), a 1994 statute of United States Federal legislation, which
defines and regulates dietary supplements, which to a great extent gives
clarity on supplements; Lack of regulation on dietary ingredient; Lack of the
date, which is used to define new dietary ingredient; Labelling requirement for
supplements including any disclaimers; Some given claims, which can be made
based on the ingredient e.g. calcium osteoporosis, Psyllium husk - cholestoerl
management as US DSHEA/ Food and Drug Administration (FDA) allows. However,
there is a guideline or regulation for food for special dietary uses (FSDU)/
Nutraceuticals/Functional food is under review stage at FSSAI scientific
panel."
Looking pragmatically at the
opportunities and challenges, Sandeep Gupta, Vice-Chairman, Nutraceutical
Sub-Committee, Indian Drug Manufacturers' Association, pointed out that the
industry bodies and government to form a platform to have common consensus in
order to prevent and repair damages rather evolves ideas to build the strength
of this sector.
Gupta further said, "We need to
take up positive initiatives and quick actions to foster nation’s objective to
arrest further malnutrition, under nutrition and meeting adequate/ appropriate
nutrition through awareness of nutrition through various routes and facilitate
good health together for better tomorrow and rise up on to the global map. Food
industry is one such platform and medium, which would help attain such status.
Earlier the better we come together before these ambiguous regulations/
governance turns up to just debate and then finally into legal battle which
will affect our people’s health. We need to create positive actions to move
forward."
Echoing similar thoughts, Dr Ghosh
of Nutriconnect said, "FSSAI needs to take steps for introduction of
industry self-regulation and joint regulation with industry bodies besides
providing better intellectual property protection and introduction of
commercial incentive to innovative companies, who are investing money for
product development and human trial."
"The new system can benefit the nutraceutical industry if the government
brings in separate rules for proprietary foods, nutraceuticals, etc.; appoint
panellists, who have worked in nutraceutical industry for 5-10 years and
handled products (sales & marketing - not mere R&D, research) and
medical doctors, especially with nutra background, who should be a guiding
force rather than government officials associated with research, analysis etc
of foods," Dr Sanghavi added.
Dr Baidyanath Mishra said,
"FSSAI would work towards providing cut-edging technology in processing,
provide a clear cut traceability mechanism, proper implementation of food
safety management system in every premises, consumer friendly promotions with
proved claims, encourage the clinical trial proven health beneficial or disease
reduction claims, and most crucial is to provide best of the best products
within reach of common people."
Sharing her comments Neeraja Shetty,
Director and President, Strategy and Business Development, Sami Labs, said,
"The new reforms and regulations will bring in a sense of clarity in the
regulatory guidelines, the lack of which had given rise to various spurious products
in the market, poor in quality, unscientific in claims and no safety data. The
12th plan was initially scheduled to sanction Rs 5,000 crore to strengthen
FSSAI. However, the authority received Rs 2,350 crore, which will definitely
create a deficit and hamper and delay FSSAI’s plans of improving
infrastructure, staffing and setting up new testing labs."
Despite shortfall in the budget, to a large extent FSSAI has created a level
playing field among stakeholders of the industry, which is waiting to see the
authority to build strength, regulate the market and streamline and accelerate
the process of product approvals to that the local nutraceuticals industry can
become a leading player in the global market.
The government should offer incentives to the industry like tax and excise
holidays. This will encourage more and more Indian companies to set up
nutraceutical industries. “Government can also help domestic entrepreneurs
through identifying and setting up channels for exports. Infrastructure for
research, forming industrial layouts for nutraceutical units etc., can go a
long way in further catapulting the growth of this sector in India, “added V S
Reddy of British Biologicals.
"I see a very significant
attention to nutrition and the involvement of many nutritionists in the process
of developing the regulations and standards. The Indian government clearly do
not only address safety (which is the focus of e.g. the EU, USA, Japan, Korea,
etc.) but also pay, rightfully, much attention to nutrition. The health of the
consumers and particularly children is at least equally influenced by
sufficient intake of essential nutrients as by contamination of food by harmful
substances and microbes," concludes Prof Huub L M Lelieveld, President of
Global Harmonization Initiative (GHI).
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Regulatory Challenges
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1. Lack of establish rules &
regulations for nutraceutical products, current governance have no clarity of
operating segment in Healthcare sector under Section 22 (Proprietary Food).
2. Ingredient standardisation will help create good standards and safety
control rather asking for Product Approval which is making chaos and delaying
execution of rules and regulations affecting the whole food industry.
3. Exorbitant application fees for approval, no rationalisation which is
unpractical affair this percolates down and impact the operational economy
especially for Micro and Small companies.
4. Referral of product for Scientific Committee assessment (with additional
equal fees paid extra) for simple nutraceutical ingredients which are already
in market overseas, even in India since years and having ample documentation
on net. This system not forming specific rules under section 22 by itself
will defeat the purpose for process. FBOs, inclusive of all streams, need final
rules to comply will lead to challenges for both the government and industry.
5. Site approval ‘dependant’ on Product Approval.
6. Exorbitant repeated cost incurred by the FBOs travelling to Central Office
for application filings. Lack of State/Zonal interface for PA applications.
7. Variable advisories without established rules causing phenomenal
confusions and uncertainties - resulting filing or re-filing of the dossier
already with duplication of fees.
8. New Business Opportunities/New Entrants/Innovation has become standstill
impacting the complete sector under such ambiguous law with no clarity.
Segregation of Proprietary Food rules is a must or else would be death of 9.
Nutraceuticals sector in India as such we are invisible on the global graph.
9. Product rejection done without scientific reasoning when Section 22 has
not been framed.
10 Lack of healthy dialogue with industry bodies to form co-operation by
government and industry by understanding practical experiences, difficulties,
limitations impacting ultimate to consumers with such uncertainties causing
confusion and also considering the situation when future disease risk is very
high if not supported with good and right supplements at the right time
11 RDA for nutrients imposed rather than upper tolerable limits which is the
global norms to have better control of safety parameters and offer
appropriate benefits of supplements in specific conditions/needs of
individuals for good health. Early conclusions without evaluation and healthy
dialogue will be the loss of good health for Indian Population.
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